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Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC Clinical research trials and Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC. Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC clinical trial. Human subjects frequently get the finest healthcare available for their Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC  Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC
Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC
For Condition: Carcinoma, Non-Small-Cell Lung,Lung Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC.
Details: This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day) continuous infusion followed by a bolus of cisplatin for previously untreated patients with stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II study is to determine the response rate of this infusional paclitaxel and bolus cisplatin regimen in patients with advanced NSCLC. In addition, the plasma levels of paclitaxel will be measured, and the in vitro paclitaxel chemosensitivity of the tumor cells from as many patients as possible will be determined. This will allow further study of the relationship between in vitro drug sensitivity, achievable plasma concentrations of paclitaxel, and patients' response to therapy.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, Mixed histologies in the absence of a predominant small cell component. Eligible Stages Include: Stage IV, Stage IIIA/B ineligible for resection or radiotherapy, Postsurgical recurrence that is histologically or cytologically proven. CNS Metastases Allowed Provided: Radiotherapy completed prior to entry. No requirement for concurrent steroids. No carcinomatous meningitis. No epidural metastases. Measurable disease not required. PRIOR/CONCURRENT THERAPY: Biologic Therapy: Not specified. Chemotherapy: No prior chemotherapy for lung cancer. Endocrine Therapy: Not specified. Radiotherapy: No prior chest irradiation for lung cancer. Surgery: Prior surgery allowed. PATIENT CHARACTERISTICS: Age: 18 and over. Performance Status: ECOG 0-2. Hematopoietic: Absolute granulocyte count greater than 2,000. Platelet count greater than 100,000. Hepatic: Bilirubin no greater than 1.5 mg/dL. Renal: Creatinine no greater than 1.5 mg/dL. Cardiovascular: No CHF unless fully compensated. No second- or third-degree heart block. No uncontrolled, symptomatic atrial dysrhythmia except sinus bradycardia. No sustained ventricular tachycardia. No MI within 3 months. OTHER: No uncontrolled infection unless due to an obstructed bronchus. No major psychiatric problems requiring hospitalization. No psychotropic medications such as phenothiazines. No contraindication to transfusion, if required. No second malignancy within 5 years except: Nonmelanomatous skin cancer. In situ cervical cancer. No pregnant or nursing women. Effective contraception required of fertile patients.
Total Enrollment: 58
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950198; 95-C-0198
Study Start Date: September 26, 1995
Record last reviewed: July 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001450
Other Lung Neoplasms Studies:
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2. This study is to assess the efficacy and safety of ZD6474 in subjects with Non-small cell lung cancer.
3. A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin vs. Placebo in Combination with Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer
4. A Phase 2 Trial of Antisense Nucleotide to PKC-alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients with Advanced, Previously Untreated Non-Small Cell Lung Cancer.
5. ALIMTA plus Carboplatin as Front-Line Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial.
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Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients with Stage III/IV and Relapsed NSCLC
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